Necessity for next-generation quality assessment of CAR T cell manufacturing and advanced therapy guidance

Despite encouraging clinical results in B-cell malignancies, redirected chimeric antigen receptor (CAR) T cells bear several medical and economic challenges. On the one hand, increasing numbers of patients require reproducible and automatic manufacturing of high quality, clinical-grade CAR T cells retaining the expression of the CAR gene and their catalytic function as well as respective biomarkers to predict processing failure, which is lacking so far. On the other hand, there is an increasing interest in advanced biomarkers for therapy guidance and especially, for preclinical testing to assess side effects such as CRS and CRES.